Promethazine compared with metoclopramide for hyperemesis gravidarum a randomized controlled trial

• Main Authors: Tan, P.C., Khine, P.P., Vallikkannu, N., Omar, S.Z.
• Format: Article
• Published: 2010
• Subjects: R Medicine; RG Gynecology and obstetrics
• Online Access: http://eprints.um.edu.my/10848/; http://journals.lww.com/greenjournal/Abstract/2010/05000/Promethazine_Compared_With_Metoclopramide_for.16.aspx

OBJECTIVE: To compare the effects of promethazine with those of metoclopramide for hyperemesis gravidarum. METHODS: Women at their first hospitalization for hyperemesis gravidarum were approached when intravenous antiemetic therapy was needed. They were randomly assigned to receive 25 mg promethazine or 10 mg metoclopramide every 8 hours for 24 hours in a double-blind study. Primary outcomes were vomiting episodes by diary and well-being visual numerical rating scale score (10-point scale) in the 24-hour main study period. Participants also filled out an adverse-effects questionnaire at 24 hours and a nausea visual numerical rating scale score at recruitment and at 8, 16, and 24 hours. RESULTS: A total of 73 and 76 women, randomized to metoclopramide and promethazine, respectively, were analyzed. Median vomiting episodes were one (range 0-26) compared with two (range 0-26) (P=.81), and well-being visual numerical rating scale scores were 8 (range 1-10) compared with 7 (range 2-10) (P=.24) for metoclopramide and promethazine, respectively. Repeat-measures analysis of variance of the nausea visual numerical rating scale scores showed no significant difference between study drugs (F score=0.842, P=.47). Reported drowsiness (58.6 compared with 83.6, P =.001, number needed to treat to benefit NNTb 5), dizziness (34.3% compared with 71.2%, P<.001, NNTb 3), dystonia (5.7% compared with 19.2%, P=.02, NNTb 8), and therapy curtailment owing to adverse events (0 of 73 0% compared with 7 of 76 9.2%, P=.014) were encountered less frequently with metoclopramide. CONCLUSION: Promethazine and metoclopramide have similar therapeutic effects in patients who are hospitalized for hyperemesis gravidarum. The adverse effects profile was better with metoclopramide.